CN106974745A - System and method for assembling the percutaneous valve folded - Google Patents

Abstract

The invention provides a kind of percutaneous valve device of multi-part (module), the percutaneous valve device includes the valve module with valve leaflet and valve frame.The valve frame includes one or more such as two ring elements and multiple pillars.The valve frame of the pivotal point with the junction being located between pillar and the first and second ring elements specially designed is additionally provided to help to fold the valve module and minimize delivery diameter.The valve frame can also include thread guide to combine the valve module with supporting module.The pillar or ring of the valve frame can also include being used to close the valve module and the valve module are fixed to the locking component such as lock shaft of the supporting module.The supporting module include be directed at the lock shaft in the valve module for by the valve module assembled and being locked to the corresponding locking component of the supporting module and for example locking fork.

Description

System and method for assembling the percutaneous valve folded

The application is that female case is that (national applications number is 201380025158.8, entitled " to be used for for application for a patent for invention The system and method for assembling the percutaneous valve folded ", are on November 13rd, 2014 into thenational phase day, and international application no is PCT/IB2013/001819, international filing date be on May 14th, 2013) divisional application.

The U.S.Provisional Serial No.61/688,470 submitted this application claims on May 15th, 2012 priority Rights and interests, this application is by reference in full comprising herein.

Technical field

The present invention relates to the system and method for disposing and assembling the percutaneous valve device of modularization.Specifically, it is described Modularization valve device includes new feature in order to which the folding and assembling of the valve module, and the system include being used for The new feature for the EM equipment module is disposed, combining and being fixed together.

Background technology

Human body include wide variety of natural valve, such as such as cardiac valves, esophagus and stomach valve, small intestine valve and The valve of valve in lymphatic system etc.Natural valve is degenerated because of a variety of causes of such as disease and aging etc.Function Dyskinetic valve can not keep body fluid to be flowed towards single direction, there is the small pressure loss.One example of dysfunction valve Son is such cardiac valves, the cardiac valves or may be made narrow, i.e. the leaflet of valve is not opened fully, or It is probably reflux, i.e. the leaflet of valve is not correctly closed.Wish to recover valvular function so that associated with the valve Organ regain normal function.For example, the normal valve function in heart ensures that blood is kept towards the flowing of single direction By valve, the pressure loss is minimum so that can keep circulation and the pressure of blood.Similar, normal esophagus valvular function Ensure that acidic stomach secretion does not stimulate or permanently damaged esophagus inner membrance.

Several percutaneous reparation valve system is had been described above.At (United States Patent (USP) No.5,411,552) such as Andersen Described in an example include expandable stents and the before deployment foldable valve on the support.Foldable valve Film can be made of biology valve or its can be by synthetic material.Anderson reparations are carried out with valve using foley's tube Conveying and deployment, the sacculus are used to valve-stent prosthese being expanded to its final size.Referring further to entitled " Valve Prosthesis for Implantation in the Body " United States Patent (USP) No.6,168,614 (Andersen etc.) and Entitled " System and Method for Implanting Cardiac Valves " United States Patent (USP) No.5,840,081 (Andersen etc.).

Spenser etc. (United States Patent (USP) No.6,893,460) describes another reparation valve device, the reparation Include valve structure and the supporting support being made up of biomaterial or synthetic material with valve device.Spenser reparation valves Be one kind can crimped leaflet formula valve assemblies, the component is by the pipeline group being made up of pliable material with entrance and exit Into, be arranged to it is described outlet provide foldable wall.The valve assemblies are fixed to supporting support before deployment.Use portion Equipment such as foley's tube or similar equipment are affixed one's name to by the target placement in complete valve device deployment in vivo delivery pipe.

Being percutaneously implantable for reparation valve is safe, cheap, and there is provided the patient shorter than standard surgical Recovery time.But, current artificial percutaneous reparation valve also has volume great in the case of conveying is compressed Shortcoming.This bulky problem is that requirement delivery conduit has sizable diameter.Larger conduit be generally not suitable for through Skin is performed the operation, and needs to cut surgical operation and/or complicated and difficult puncture-closure techniques.Current valve device it is big The anatomical position that volume and major diameter and induction system and the equipment are necessarily conveyed through from success rate, deployment correctness With also to deliver into inner chamber from the viewpoint of the risk of complication as problem.Especially since importing conduit by it Inner chamber shape, for example the arch of aorta and/or complications ilium/femoral artery obvious natural torsion, may cause defeated Send complication.Moreover, the flexible conduit for being often not so good as small diameter that the conduit with this diameter has, is especially being used In the case that the non-flexible equipment of large volume is loaded.In addition, this loaded conduit of operation passes through narrow vascular especially The vascular of bending significantly increases the possibility that damage, bleeding and other vascular complications are caused to the blood vessel wall, this It is again relevant with higher morbidity and mortality.

Further, valve leaflet material constitutes 80% percutaneous reparation valve delivery diameter.Make valve leaflet material at present Volume minimization effort including the use of relatively thin valve material or close crimped valve leaflet.Both approaches are small to valve The durability of leaf generates detrimental effect, and later approach produces the detrimental effect because damaging valve material.

Therefore, there are needs to the security for conveying and also increasing operation for being easy to artificial valve.It is highly desirable to have Than the small delivery diameter of assembling front lens valve device and can by vascular conveying without the wall to bodily lumen cause into The valve device of the damage of one step.It is also desirable that the offer with compared with little profile (small delivery diameter) is set in operation reparation with valve The percutaneous reparation valve device of the utilizable durable type of leaflet in standby.

US publication application No.2010/0185275A1 (being herein by reference incorporated herein its full text) is retouched A kind of percutaneous valve device of modularization (multi-part) is stated, the percutaneous valve device is used as and can planted in the blood vessels by providing Enter position or be nearby assembled into work structuring can conveyor module and be easily repaired the conveying with valve.US publication Application No.2010/0185275A1 also describes the various elements for the apparatus module assembled to be locked together.

US publication application No.2011/0172784A1 (being herein by reference incorporated herein its full text) is retouched A kind of percutaneous valve device of such modularization (multi-part) is stated, the percutaneous valve device, which has, to be easy to assemble in the blood vessel The self assembly component of modularization reparation valve.US publication application No.2011/0172784A1 is also described Now it is different from the valve module of the shape (unassembled shape) of their function valve shape, such valve module is used for what is conveyed It is particularly advantageous in that unassembled shape allows the Fold Flap film module in the way of minimizing the delivery diameter of equipment, thus Make complication minimum and add the security of valve replacement surgery.

The content of the invention

The invention provides a kind of improved percutaneous valve device of modularization and system, the equipment and system, which have, to be simplified The part of the assembling of EM equipment module.Specifically there is provided for dispose and assemble percutaneous modularization valve device system and Method.Described multipart or modular percutaneous valve device and system include multiple valve modules for being used to convey. In one embodiment, the multiple EM equipment module includes valve module and supporting module, and they are designed in vivo by group It is combined into assembled valve device.From the perspective of function, the valve module is the lobular part of tool of valve device, After assembling, it provides the pipeline with access end and outlet ends.The supporting module provides the equipment Deadman or skeleton, house the valve module and are held in place the valve module in bodily lumen.Through flap In film replacement operation, natural valve leaflet is typically what is do not removed before implantation reparation is with valve；Therefore, supporting module Also act as and outwards shift the natural valve leaflet to form the effect of larger valve orifice, especially using reparation valve Come treat actively affectionately valve it is narrow in the case of.

The valve module of the present invention is provided with valve frame, the valve frame have one or more ring element and with Multiple pillars of one or more of ring element connections.One or more of ring elements are discrete, each tools There are first end and second end, thus allow the ring element to open to be folded.This, which is provided, has unassembled folding The valve module of folded delivery configuration, wherein the ring element of one or more of openings and the pillar are substantially conllinear , and folded together with the valve leaflet.Term " collinearly " and " substantially conllinear " can exchange use herein, And refer to along substantially common direction and/or linear neighboringly extension transmission.Thus, for example, in delivery configuration, " folding It is folded " pillar put substantially in parallel with one or more of ring elements.In one embodiment, in the pillar One pillar can be dissection type pillar, and the first half portion of the dissection type pillar is located at one or more ring element At the first end, and the second half portion is located at the second end of one or more ring element.

The valve module also has work structuring, and the end of one or more ring element is close (that is, closed together, adjacent to each other) to form ring, longitudinal axis of the pillar along the valve relative to one or The multiple ring elements of person are orientated substantially uprightly.The valve leaflet is attached to ring element, for example, be attached to positioned at the valve The ring element of the base portion of film module, and in the embodiment with the first ring element and the second ring element, the valve is small Leaf can be supported by second ring element.As substituting or as other embodiment, the valve leaflet can be by One or more pillar support in the multiple pillar.

The supporting module has the delivery configuration of compression and the work structuring of expansion, wherein it is possible to insert and be attached Valve module.In one embodiment, the supporting module has the delivery configuration of radial compression, and can be with radial development To the work structuring.

The valve module and the supporting module may further include to be easy to the valve module booting extremely together The supporting module by the valve module and the supporting module to combine, close the valve module to form pipe Road and the new structure that the valve module is locked to the supporting module.These novel features can include lock shaft and Locking fork, thread guide and assembling silk thread.It is described locking fork can include be used for operationally with the thread guide one Rise using the eyelet so that the valve is led into the supporting module along assembling silk thread.Such as thread guide, hole The element of eye and assembling silk thread etc can also be referred to as " guiding elements " herein.The lock shaft and the locking are forked The valve module is locked to the effect of the locking component of the supporting module.Other kinds of locking component can be used, For example, snap-fastener or other geometry locking mechanisms.The relative position of the locking component can according to embodiment it is different without Together.For example, the lock shaft can be positioned on the part of the valve frame, and the locking fork can be positioned at the branch On hold mode block.Alternatively, the locking fork be can be positioned on the valve frame, and the lock shaft can be positioned In the supporting module.

Include the first ring element and the second ring element in the valve frame and be arranged in first ring element and institute In an embodiment for stating the multiple pillar between the second ring element, the connection between the pillar and the ring element It can be new pivotal point connection.The pivotal point connection is easy to make in the connection while valve frame is folded Physical strain is minimum.In another embodiment, the valve frame include be located at base portion at the first ring element and via The multiple pillar that new pivotal point is connected and is connected with first ring element.

The system of the present invention includes above-mentioned modularization valve device and the induction system including conduit and assembling silk thread.At certain In a little embodiments, the induction system further comprises pushing meanss, and the pushing meanss can be on the assembling silk thread Advance so that the valve module is slid into the supporting module on the assembling silk thread, and can further be used To lock the locking component.In including some of thread guide embodiments, each assembling silk thread can be described in Thread guide is so that the entanglement of the assembling silk thread is minimized.Include having the one of perforated locking fork in the supporting module In a little embodiments, the assembling silk thread can additionally pass through the eyelet, in order to which the silk thread is by the silk thread An end on drawing and be implanted into after from the valve device depart from.Alternatively, the assembling silk thread can be passed through A part for the supporting module and/or the valve frame.

Additionally provide the method for assembling the percutaneous valve device of modularization using the novel features of the system.The valve Film module is advanced on the assembling silk thread and the thread guide can be used for the valve module is oriented and assembled simultaneously The supporting module of the valve module and expansion is combined.In one embodiment, the valve module can With including lock shaft (tubulose or ring-type structure), and the supporting module can include locking fork, and the locking fork be The position phase with the lock shaft being attached for being connected with the lock shaft, in the position of the circumference of the supporting module Corresponding application specific architecture.The lock shaft can be for example positioned on the pillar and/or ring element.When being positioned at the valve When on the pillar of framework, the lock shaft can be positioned in outer surface or inner surface or some of combination of the pillar. In another embodiment, the lock shaft be can be positioned in the supporting module, and the locking fork can be positioned In the valve module.In any embodiment, the lock shaft can pitch neatly movement simultaneously in the locking And can lock in place.Using in the case of dissection type pillar, the dissection type pillar can include a pair of locking axle- There are a lock shaft, the lock shaft and the locking in the supporting module in each half portion of the dissection type pillar Fork combines and is closed at the ring element and is locked to the valve module with realizing work structuring valve module and realizing The supporting module.

The present invention the percutaneous valve of the modularization advantage be valve module easily fold with conveyed and Approximate assembled configuration is easily varied into after conveying equipment deployment, and support is provided for the valve leaflet.The institute of the present invention State the advantage of system include being easy to open the valve module and by the valve module assembled into the work structuring, make it is described Valve module is aligned to combine the EM equipment module and the EM equipment module is fixed into mutual set with the supporting module Meter.Yet another advantage of the present invention is that because valve device is modular, therefore can independently optimize the property of the module Can, because valve module and supporting module have different function-valve modules regulation and control blood flows and supporting module is by valve grappling In valve annulus and (pin) is followed closely at the back side of natural valve leaflet；Independently dispose the module and by their combined in-situs Alleviate the necessary design trade-off when the valve device is individual unit.

Other advantages that the present invention can be realized, which are included in while reducing the volume for the valve conveyed, keeps described The durability of valve leaflet and the flexibility for adding conveying device.Moreover, repairing minimally invasive with valve device, and pass through The method of skin conveying reduces traumatic damage and makes postoperative complication minimum, but also allows to be delivered to compared with scun Pipe, severe disease, the patient of complications or the vascular blocked, and reduce the risk of vascular complication.Use the dress of the present invention Standby, system and method, which thus can provide the security of operation and expand, can enter the medical treatment of percutaneous valve replacement surgery The quantity of facility and the quantity for being capable of patient receiving treatment.

Brief description of the drawings

Fig. 1 is the schematic diagram of the bicyclic embodiment of the valve module of the displaying present invention.

Fig. 2 schematically illustrates the valve frame in its unassembled substantially flat construction, it is shown that pivotal point An embodiment.

Fig. 3 A-B illustrate another embodiment of the valve frame with horse's hoe shape pivotal point.Fig. 3 A are schematically opened up The valve frame in its unassembled substantially flat construction is shown；Fig. 3 B illustrate schematically how the valve in Fig. 3 A The shape of a hoof pivot point connection ring element and pillar of framework embodiment.

Fig. 4 A-B are the figures of the embodiment of Fig. 3 A valve frame of the displaying in its work structuring.Fig. 4 A illustrate Fig. 3 A Valve frame embodiment top view；Fig. 4 B shows side view of Fig. 3 A valve frame embodiment.

Fig. 5 is that the embodiment for illustrating bicyclic valve module can fold to be loaded into delivery conduit according to the present invention A kind of mode figure.

Fig. 6 A are illustrate the bicyclic valve module for being folded and being loaded into delivery conduit according to the present invention one The schematic diagram of embodiment.

Fig. 6 B be illustrate according to the present invention from an embodiment party of the bicyclic valve module during catheter deployment The schematic diagram of formula.

Fig. 7 A-E are the methods for illustrating an embodiment according to present invention deployment and assembling modularization valve device Figure.

Fig. 8 A-B illustrate the embodiment how valve module and supporting module can connect.Fig. 8 A are to show How lock shaft in valve module can be connected to has deltoid muscle shape or " Kite " locking fork in supporting module The schematic diagram of the locking fork of jaw；Fig. 8 B schematically illustrate identical content.

Fig. 9 A-B illustrate an embodiment of locked component.Fig. 9 A are to illustrate the first lock in valve module Dead axle and the second lock shaft and thread guide and the schematic diagram for assembling silk thread through these structures.Fig. 9 B are schematically opened up How shown Fig. 9 A first lock shaft and the second lock shaft can be connected to the locking fork of supporting module.

Figure 10 A-B illustrate an embodiment of locked component.Figure 10 A are to show the ring lock in valve module How dead axle can be connected to the schematic diagram of the hybrid locking fork in supporting module；Figure 10 B are to show to be locked in described mix The illustration of the ring lock dead axle on box-like locking fork.

Figure 11 A-C.Figure 11 A schematically illustrate the hybrid locking fork；Figure 11 B, which are schematically illustrated, to be directed Ring lock dead axle onto the hybrid locking fork；Figure 11 C, which are schematically illustrated, is locked in the hybrid locking fork The ring lock dead axle.

Figure 12 A-B schematically illustrate an embodiment of the hybrid locking fork of single-groove groove.Figure 12 A are shown in the past The embodiment coupled via ring lock dead axle with pillar of face viewing.Figure 12 B are to be used to disclose locking fork and ring junction The sectional view of the same view of structure.

Figure 13 A-B schematically illustrate an embodiment of the hybrid locking fork of single-groove groove.Figure 13 A are shown in the past The embodiment coupled via lock shaft and ring lock dead axle with dissection type pillar of face viewing；Figure 13 B are to be used to disclose described The sectional view of the same view of locking fork, lock shaft and annular lock axle construction.

Figure 14 A are the schematic diagrames of the exemplary valve frame for the valve module according to the present invention.

Figure 14 B are the schematic diagrames of the exemplary supporting module according to the present invention.

Figure 14 C are the schematic diagrames of another exemplary supporting module according to the present invention.

The embodiment that the hybrid locking that Figure 14 D are showing in the exemplary supporting module according to the present invention is pitched Details schematic diagram.

Embodiment

The invention provides a kind of implantable modularization percutaneously reparation valve device, for disposing and assembling implantable warp The method and system of for example percutaneous modularization heart valve devices of skin modularization valve device.

The percutaneous valve device of the present invention includes being used for the multiple equipment mould of for example intravascular conveying and assembling in body cavity Block.These EM equipment modules can percutaneously be delivered to internal desired location, be for example delivered to valve implantation near sites or The position of valve implantation, at the position, they can dispose and assemble from conveying equipment and be set with forming work valve It is standby.The multiple EM equipment module can include supporting module and valve module.The supporting module has the delivery configuration of compression With the work structuring of expansion.The valve module includes the valve leaflet of valve frame and valve device；The valve leaflet can To be attached to the part of the valve frame, the valve frame include one or more ring element and with it is one or Multiple pillars of multiple ring element connections.

The valve module has unassembled open configuration, wherein one or more of ring elements have fundamental line Property i.e. substantially straight construction, and the valve leaflet puts substantially flatly.It should be understood by those skilled in the art that It is that valve leaflet, which has, includes the shape at such as abutment, therefore term " substantially flat " can include some fluctuatings.It is this not The open configuration of assembling allows main folded on " longitudinal direction " of valve module for example to wind up into the delivery configuration through folding, and institute Work structuring can be assembled into from the delivery configuration through folding by stating valve module.In the unassembled open configuration, The valve module has along the width (i.e. from summit to the width of base portion) of its longitudinal axis and along linear circumferential axis Length, i.e., along one or more of ring elements first end and one or more of ring elements second end The length of the axis limited between end is (or in the embodiment with dissection type pillar, along the first pillar half portion and The length of the axis limited between two pillar half portions).Therefore, " longitudinal direction " is readily appreciated by one skilled in the art to refer to along length Degree, such as from a dissection type pillar half portion to the length of another dissection type pillar half portion.It is described many in its folded structure Individual pillar can fold substantially conllinear with the ring element with substantially linear to one or more of ring elements.

" longitudinal direction " of the valve module, which is folded, is easy to the delivery configuration with minimum diameter, and makes to the crimped of leaflet Damage (crimping damage) to minimize, hence improve durability.Specifically, valve mould is predominantly longitudinally folded Block is distributed the volume of leaflet material for radial folding or compression on longer axial distance so that led in conveying Any point in pipe has less valve material.As a result, less crimped power is needed on leaflet (with presently commercially available equipment Radial direction crimped compare) realize small delivery diameter.Advantage obtained is that less crimped damage is caused to leaflet material, And therefore improve durability.In addition, it is not necessary that realizing less conveying profile using relatively thin valve material (profile).This primarily longitudinally fold favourable example includes for example spirally winding up opening around guide line Unassembled valve module.Another example is when the multiple pillar is folded towards one or more of ring elements Crispatura (scrumch) valve material.

In some embodiments, special connection-pivotal point of the pillar and ring element-can be in order to folding.When When being assembled into work structuring, the valve module provides the pipeline with access end and outlet ends.The valve frame One or more close ring element of end can be included in its work structuring and determined along the longitudinal axis of the valve To multiple pillars, pipeline is thus formed together with valve leaflet.The valve leaflet can be by the pillar and the ring structure One or more support in part.

The valve frame can be made up of any materials in various materials, and these materials are, for example, such as shape memory Alloy be cobalt chromium (a kind of material with superelastic properties) or polymer can deformation plastics etc material.In an implementation In mode, the valve frame includes shape memory metal or alloy, and it is nursed one's health (pre-condition) to be back in advance Pre-set configuration.One side preferably, the valve frame is made up of marmem.The pre-set configuration can To be referred to as the first construction (such as releasing orientation), and the delivery configuration be properly termed as the second construction (such as it is not unclamping or The affined construction of person).The valve frame can be triggered for example, by the change (heating or cool down) of temperature, electric current To be back to the pre-set configuration, or if the valve frame has superelastic properties it can limit shape from geometry State is discharged, or it can be expanded and mechanical crust deformation or " triggering " using sacculus, and the sacculus expansion can for example trigger example As NiTi is converted to the transformation of different phases.The marmem allows valve frame thermomechanically to be nursed one's health in advance to pre- Selected shape (pre-set configuration) so that it in one embodiment can be with the second of for example relatively straight still axial elasticity Construction is conveyed, and is then triggered and is back to thermomechanically default first construction.In another embodiment, convey Inner chamber in equipment or conveying equipment can constrain in valve frame delivery configuration, and it can be from the constraint to trigger Middle release.

" pre-set configuration " or " the first construction " used herein for valve frame is not limited to shape memory structure.It is " pre- If construction " or " the first construction " refer to that pre-selection that is that valve frame is presented after being disposed from conveying equipment or returning to is shape-selective Shape.In the case where valve frame is for example back to its first construction by temperature step, the temperature step can pass through example As described in being changed with hot fluid, cold fluid, body heat or the resistance heat that passes the current through silk thread and produce around valve frame Temperature in environment is realized.Any shape memorial alloy may serve to manufacture shape memory valve frame.It is specific at some Embodiment in, used marmem is NiTi (that is, NiTinol), CuZnAl, CuAlNi or theirs is mixed Compound (is compiled, Cambridge University see, for example, Shape Memory Materials, Otsuka and Wayman Press；In October, 1999 and Shape Memory Alloys, Youyi and Otsuka are compiled, International Academic Publishers, in June, 1998).

The valve leaflet material can be by appropriate material such as polymer, metal or biomaterial as being derived from for example The mammal pericardium (pericardium) of ox, pig or horse tissue is manufactured.The selection of material, structure and manufacture method Preferably so that the function of the valve, durability and biocompatibility are optimized.The valve leaflet can pass through this area In known means for example by suture, it is gluing, cohere (bonding) or the valve be attached to by methods described below Framework.

The supporting module is preferably extensible so that its can compress it is (not deployed) convey and then deploy with Carry out the implantation and assembling of the valve device.The supporting module can be by that can support the valve assemblies with structure The biomaterial manufacture of the sufficient durability of the position of equipment in inner chamber is maintained at simultaneously.The supporting module material also have with The conveying of the supporting module of compressive state and the compatibility for disposing the expansion of compression supporting module when in the lumen.For example, institute Stating supporting module can be by various material manufacture, and these materials include marmem cobalt chromium, and (one kind has superelastic properties Material) or polymer can deformation plastics.In an embodiment of the invention, the supporting module by stainless steel or Marmem such as Nitinol is manufactured.In another embodiment, the supporting module can be by with appropriate atom The amorphous metallic alloy manufacture of composition, as known in the art.The other embodiment of the supporting module can be with Manufactured by similar biocompatible materials known in the art.One non-limitative example of appropriate supporting module is webmaster (mesh tube).In this example embodiment, the supporting module includes hollow basic cylindrical shape (ring-type) component, and the component has Side surface including net, the net has multiple holes or cave nest (cell).The supporting module has enough radial directions long Spend with dispose kept after the supporting module its position of implant site, with outwards shift natural valve leaflet and To form the big valve orifice of the morbidity valve than preparing displacement.The supporting module can be that the either sacculus self-deployed can Expansion.Example for the supporting module of the present invention is well known in the art.

The supporting module can include locking component, such as those locking components described herein, by the valve Module is fixed in the supporting module.The supporting module may further include hook, rib (rib) or other anchoring arrangements with It is easy to being anchored into assembled valve device into natural anatomical position (anatomy) such as valve annulus.The supporting module with The connection of valve annulus and/or the connection of the valve module and the supporting module can be designed to provide to these structures The regulation of relative position.

The apparatus and method of the present invention are particularly suitable for the displacement of percutaneous aortic valve film, but can be used for other hearts The displacement of dirty valve, such as such as lung bicuspid valve and tricuspid valve and external perihaemal canal or the valve in other bodily lumens Displacement, for example alimentary canal, lymphatic vessel, bile duct and any other have need replacement valve or need be implanted into valve inner chamber in Valve displacement.In the case where modularization valve device is designed to displacement aortic valve, it can be assembled In a part and sustainer in aorta ascendens, in descending aorta, in left ventricle, at implant site or at implant site A part of position at.Although being particularly suitable for the inner chamber of human body, the equipment, system and method can also Applied to animal.

Below in reference to accompanying drawing discussion and explanation aforementioned embodiments and other embodiment.Accompanying drawing is used as the present invention's It is exemplary that offer is provided, and schematically illustrate only certain exemplary embodiments of this invention.Those skilled in the art should be easy Recognize other similar embodiments equally located within the scope of the present invention.The purpose of accompanying drawing is not limited to such as appended right The scope of the invention that claim is limited.

As described above, the modularization valve device of the present invention includes valve module and supporting module, they can be with non-group The delivery configuration of dress is conveyed, and is assembled and combined after being disposed from conveying equipment.The valve module includes attached It is connected to the valve leaflet of valve frame.Partly assembled valve frame and the illustrative representations of the supporting module of expansion are shown respectively In Figure 14 A and 14B.The valve module and its details being connected with the supporting module are provided in Fig. 1 to 13.

Fig. 1 illustrates a non-limiting embodiment of valve module invention, and wherein valve frame includes the first ring structure Part and the second ring element.As shown in figure 1, including valve leaflet 15 and valve frame in the valve module 10 that its assembly working is constructed Frame.The valve frame includes the first ring element 21 and the second ring element 22 and multiple pillars 25,28a, 28b, such as three Pillar, first ring element 21 is located at the base portion (proximal end of valve) of valve module, and second ring element 22 is located at valve The remote end (remote end of valve) of film module, the multiple pillar 25,28a, 28b are in the ring of the first ring element 21 and second Essentially perpendicularly extend between component 22, connect the ring element 22 of the first ring element 21 and second.In one embodiment, First ring element 21 is wider than second ring element 22 along longitudinal axis (referring to Figure 14 A) so that the first ring structure Thus part keeps the shape of the valve module of assembling more resistant to distortion.

Valve leaflet 15 can be attached to one in pillar 25,28a, 28b and/or the ring element 21,22 or Two.In the embodiment shown in Fig. 1, valve leaflet 15 be attached to the first ring element 21 and such as pillar 25, Hung at the point near tie point between 28a, 28b and the second ring element 22.Fig. 1 also illustrates valve leaflet 15 and is attached to Dissection type pillar 28a, 28b are not attached to the embodiment of other pillars 25 still.Valve leaflet 15 can be attached to Valve frame, for example, be attached to valve frame by suture as shown in Figure 1, or by it is known in the art it is any its He is attached to valve frame by proper method.For example, valve leaflet 15 can be hung via small leaf joint 16, such as Fig. 1,5,6A and 6B.Alternatively, valve leaflet 15 can for example, by be seamed to the second ring element 22 or pillar 25,28a, 28b or Person is hung or is attached by other modes in the art.Small leaf joint 16 can by with the identical material of valve leaflet 15 Material is made and for example, by being bonded to the second ring element 22 or their some groups by the ring sewn closed, by the circumferential weld Conjunction is fastened.Alternatively, valve leaflet 15 can be by by ring that suture or the second material are formed and from institute The second ring element 22 is stated to hang.

In one embodiment, valve leaflet material (the first material) is not to be attached directly to valve frame, but attached It is connected to the second flexible more durable material, the described second flexible more durable material is further through known in this area Method, such as cyclization, suture, it is gluing, cohere be fixed to valve frame.For valve leaflet to be attached into the one of valve frame Individual embodiment is sandwich attachment (sandwich attachment).Specifically, in terms of this, the second material wound on A part for valve frame such as ring element or column circumference, allow the second material to have enough sections beyond winding, to permit Perhaps the section of the first material is inserted between two sections of the second material, so as to form first the-the second material-the of material One material (three layers) interlayer structure.Then second material can for example be sutured by using suture and be attached to the first material Material.First material can be such as pericardium, and the second material can be such as terylene (Dacron), but can use ability Other combinations of suitable material known to domain.

Sandwich attachment embodiment can alternatively include open interlayer structure (two layers).In this embodiment, Two materials are around valve frame and be attached to itself and leave afterbody, and the afterbody can be independently by the above The mode of description is attached on a section of valve leaflet.Similar sandwich attachment can be used to design valve leaflet is attached Pillar is connected to, including the use of fin or ring to accommodate the attachment point of the locking component on pillar.One advantage of sandwich attachment is Extend the valve rigid life-span, because avoiding abrasion of the surface of valve frame to valve leaflet material (the first material).

In its unassembled folded structure, Fig. 1 the first ring element 21 and the second ring element 22 be do not close or Substantially closing structure is still to open：Substantially linear construction is each positioned at, with first end and second End, for example, as shown in figs. 2 and 3.In one embodiment, as shown in Fig. 1,2 and 3A (referring further to Fig. 9 A), the pillar In pillar dissection type pillar 28a, a 28b so that the first half portion 28a of dissection type pillar is positioned at unassembled valve mould At the first end of block, the first end of one or more ring element, and the second half portion 28b of dissection type pillar are connected to At the second end for being positioned at unassembled valve module, the second end of one or more ring element is connected to.Valve is small Leaf 15 can be for example by suture, using method as discussed above or solid by any other appropriate method known in the art Fixed each half portion to dissection type pillar 28a, 28b.

As shown in Fig. 9 A for the valve frame with dissection type pillar, ring element can be for example in the proximal end of pillar Thread guide 30 is nearby equipped with, assembling silk thread 80 can pass through thread guide 30.The proximal end is planted in valve Enter to replace during aortic valve near the end of heart.For example, as shown in Figure 14 A, the first thread guide 30 can be determined Position is on the first ring element 21 near the first half portion 28a of dissection type pillar, and the second thread guide 31 can be positioned On the second ring element 22 near the second half portion 28b of dissection type pillar.Similarly, the first thread guide 30 can also be determined Position is on the first ring element 21 near the proximal end of pillar 25, and the second thread guide 31 can be positioned at the near of pillar 25 On the second ring element 22 near end.Although not being the necessary feature of valve frame, thread guide 30,31 can be used for Assembling being correctly aligned relative to valve frame of silk thread 80 is kept when from catheter deployment valve module.

When conveying valve module, it is necessary to which valve module is folded into the delivery configuration with small diameter, but this is defeated Construction is sent in deployment to remain able to be converted to approximate tubular structure after assembling and combine with supporting module.The present invention is provided A kind of modified valve frame structure for Fold Flap film module.

Pillar is folded towards ring element may be caused to pillar and first with forming substantially conllinear folding valve frame And the valve frame material at the second tie point between ring element produces significant stress or strain.Therefore, in the present invention One side, the tie point can be designed to pivotal point 70, for example, as shown in Figure 2.Use the non-resilient company with standard Connect different pivotal points and be easy to fold valve frame to allow to make the first ring element and the second ring element and pillar basic conllinear Without result in significant material strain or stress at the tie point.Reduced via the new pivotal point of the present invention to valve frame Strain provides another advantage of such, i.e. folding the pillar and the first ring element and the second ring element of valve frame To form the cross section of minimum when enabling basic conllinear.In one embodiment, pillar and the first ring element and second Ring element is significantly more stiff than pivotal point.There are many modes to optimize pivotal point with reduce material strain at tie point or Stress, for example, plane, thickness, width or the shape of regulation connection.Two non-limits of the pivotal point for the utilization shape that can be used Qualitative example is described below, but according to these descriptions, it will be appreciated by those skilled in the art that can be used for the pivot of the present invention The other shapes of turning point.

In an embodiment of the valve frame 20 shown in Fig. 2, new pivotal point 70a, 70b can be contained in pillar 25th, it is basic S-shaped portion 71, and the first ring element 21 and the second ring element 22 are connected to right angle in 28a, 28b.Pivotal point 70a the first ring element 21 is connected to pillar 25, the orientation in 28a, 28b S-shaped portion can be with pivotal point 70b by the second ring Component 22 be connected to pillar 25,28a, 28b S-shaped portion orientation it is opposite (or contrary), as shown in Figure 2.Compare the 70a in Fig. 2 And 70b.Preferably, pillar is connected to the S-shaped pivotal point 71 of the first ring element 21 to orient with identical, and by pillar The S-shaped pivotal point 71 for being connected to the second ring element 22 is oriented with identical.S-shaped pivotal point as shown in Figure 2 can also have The width narrower than pillar.

In another embodiment of valve frame 120, as shown in figs.3 a and 3b, new pivotal point 170 can be more " horse's hoe " shape connection 75 between complexity, including first segment 121a, 122a of pillar 25,28a, 28b and ring element 121,122 Oblique connecting portion 76 between neighbouring section 121b, 122b of horse's hoe shape component 75 and ring element 121,122.Fig. 3 A are illustrated It is in the embodiment of this valve frame 120 in its substantially flat unassembled construction.Fig. 3 B illustrate pivot in further detail Turning point 170.The horse's hoe shape portion 75 for the pillar junction being connected with the first ring element 121 orientation and with the second ring element The orientation in the horse's hoe shape portion 75 of the pillar junction of 122 connections is opposite.Meanwhile, horse's hoe shape component 75 and the first ring element 121 It is oblique between the orientation and the neighbouring section of horse's hoe shape component 75 and the second ring element 122 of inclined member 76 between neighbouring section Orientation to component 76 is opposite.Compare the 170a and 170b in Fig. 3 A.Preferably, pillar is connected to the first ring element 121 Inclined member 76 and the orientation of horse's hoe shape component 75 there is identical orientation, and pillar is connected to the second ring element 122 Inclined member 76 and the orientation of horse's hoe shape component 75 there is identical orientation.Horse's hoe shape component 75 at pivotal point 170 disperses Displacement (spread displacement) so that strain is relatively low, and oblique connecting portion 76 reduces angular displacement, therefore reduction Strain.Optionally, horse's hoe shape-oblique connection pivotal point 170 can have and pillar identical width.

Alternatively, pivotal point, either S-shaped or horse's hoe shape-oblique or some other geometries, also It can be provided with or alternatively there is less thickness (such as less specification)-in other words, the part of bending can be than branch Post or ring element structure are thin, in this, as the mode of the other or replacement of the favourable geometry pivotal point shape.Branch Connecting portion between post and ring element can alternatively include hinge.

When the valve frame 120 of Fig. 3 A-B embodiment is in its work structuring, the shape of a hoof/oblique pivotal point 170 It is flat.The flat structures of the embodiment of valve frame 120 show that Fig. 4 A show top view, valve in Figure 4 A Framework is shown as two circular rings, and described two circular rings are the first ring element 121 and the second ring element 122.Fig. 4 B are shown From the embodiment party for the valve frame 120 with horse's hoe shape/oblique pivotal point 170 in its work structuring laterally watched Formula.The stereogram shows that the first ring element 121 and the second ring element 122 in this embodiment are not simple rings, but It is shown as " waveform ".By that in the first ring element and the second ring element in Fig. 4 B and embodiment demonstrated in Figure 2 A little ring elements are compared.It also show the ring lock dead axle 37 on pillar.But, the ring element of Fig. 3 A-4B embodiment 121st, 122 is basic conllinear and substantially conllinear relative to pillar relative to each other in delivery configuration is folded.

Convey valve module in order to percutaneous, pillar 25,28a, 28b can be folded into substantially linear ring element 21,22, 121st, 122 and pillar oriented in substantially common direction, to form substantially conllinear valve frame, and one or Multiple valve leaflets 15 together-can be in a spiral manner around guiding piece silk thread 86, as shown in Figure 5.Fold valve This method of module can make guiding piece silk thread 86 through the linear valve frame of spiral and the center of valve leaflet.Guiding piece Silk thread inner chamber may extend through conduit 85, and valve module 10 can be folded in around guiding piece silk thread inner chamber or fold Around guiding piece silk thread (as shown in Figure 6A), it is loaded in conduit 85 and (for displaying purpose, is shown as transparent pipe) to carry out The conveying of valve module.When disposing valve module 10, valve frame is easy to carry out valve module (Fig. 6 B) and forms basic Circular shape (Fig. 7 C, 7D).Pillar is folded downwardly on ring element to be had with the ability for forming substantially conllinear valve frame Help thus provide the delivery diameter minimized for valve module for valve frame.

Supporting module can include multiple multiple cave nests limited by microfilament or pillar, as shown in Figure 14 B, 14D (referring further to Fig. 7 A-B, 8A, 10A).Multiple cave nests can include one or more big cave nest 43, as shown in Figure 14B (referring further to Figure 10 A- B, 14C-D), with adapt to previously be implanted with modularization valve patient may needs potential blood vessel intervention operation.It is larger Cave nest 43 for for example manipulate conduit enter coronary artery provide through implantation valve entrance.

When deployed, supporting module will engage valve annulus (such as in aortic valve replacement, engagement left ventricle Room mouthful), follow closely in natural valve leaflet (if not removing) behind, to be fixed therein, so that valve mould Block is not moved and not from desired displacement in the lumen, for example because the fluid stream by valve pressure or Caused by influence to closing valve.Supporting module can also expand the valve orifice of stenosed valve.In one embodiment, Supporting module is shaped as the annular with mono-disperse, but it can also be provided with other shapes, and this plants depending on valve Enter the shape of cross section of the inner chamber at position.Thus, for example, in its deployment configuration, supporting module can be along its longitudinal axis To with non-homogeneous diameter.The proximal end of supporting module and the diameter of remote end can be with identical or differences.In an implementation In mode, as shown in Figure 14B, supporting module can have than in the small diameter of proximal end and remote end in intermediate region.At this In the embodiment of sample, the longitudinal cross-section of the center line by supporting module will have hourglass or dog-bone shapes.This shape can In order to be placed in valve annulus and/or improve the sealing for the valve for being resisted against natural anatomical position by supporting module.

As shown in Fig. 7 A-E, system of the invention includes induction system 87, and the induction system 87 includes such as conduit 85 Etc conveying equipment, for convey in its little profile delivery configuration EM equipment module and can from the construction dispose described in set Standby module.The system also includes assembling silk thread 80 and pushing member 81, the modularization valve for disposing and assembling the present invention Equipment.

The valve device of the present invention can include multigroup locking component, and multigroup locking component is designed to valve mould Block is locked to the supporting module of expansion.It can use any locking component in various locking components that valve module is locked into branch Hold mode block, or for the end of unassembled valve module to be locked to each other.The example of this kind of locking component is in United States Patent (USP) US 2010/0185275A1's83-111,113 and Fig. 7,7A, 8A-14C in have a detailed description, this application is herein by drawing It is incorporated herein with mode.As described hereinafter in greater detail, locked component is preferred.Each group of locking component can With including the first locking component and the second locking component.First locking component in the locking component group can be attached A pillar into multiple pillars of valve frame, and second locking component in the locking component group can be by It is attached to supporting module.The first component and second component in each group can be circumferentially aligned with each other, and one It is individual preferred embodiment in, thread guide is aligned in a circumferential direction with the first locking component.

First locking component and second locking component can include locking fork and the correspondence locking with inner chamber Axle, wherein, the locking fork has the first locking to pitch end, the second locking fork end and positioned at the described first locking fork end Locking fork jaw, locking fork jaw includes eyelet and slit.Therefore, in the locked component using the present invention An embodiment in, supporting module 40 have at its remote end 42 it is multiple locking fork 45,145, it is described locking fork is set Count into and be aligned with multiple lock shafts 35,135,136.In Fig. 8 A-B, 9A-B, 10A-B, lock shaft 35,135,136 or ring lock Dead axle 37 is positioned at the pillar 25 of valve frame, on 28a, 28b.In some other embodiment, lock shaft 35,135,136 Or ring lock dead axle 37 can be positioned on one or more ring element 21,22 of valve frame, or lock shaft 35,135, 136 or ring lock dead axle 37 can be positioned in the combination of pillar and ring element.The locking fork and lock shaft of locking mechanism can be with It is described referring generally to Fig. 8 A-B, 9A-B non-limiting implementation.Each locking fork 45 can have eyelet 46, assembling Silk thread 80 can pass through the eyelet 46.Referring to Fig. 8 B, 9B.Alternatively, assembling silk thread 80 can pass through supporting module A part of (not shown).

In another embodiment, locking fork 45 can be positioned on valve frame, and locking fork jaw is located at valve mould The proximal end of block, and lock shaft 35,135,136 and/or ring lock dead axle 37 can be positioned in supporting module 40.At these In embodiment, valve module can use pushing member to be forced into along assembling silk thread in supporting module, or under It is forced into as described by literary in supporting module.

Locking fork 45 can be included with the geometrical construction for preventing that valve module is moved from the remote end of supporting module Locking fork jaw 47, valve module is thus locked to supporting module.As shown in Fig. 8 A-B, locking fork jaw 47 includes flexibility Section, in this embodiment, the flexible section are designed to " Kite ".The shape of locking fork jaw 47 is designed to bending With allow using pushing member 81 make lock shaft 35 locking fork 45 locking fork jaw 47 on neatly move (see above, Fig. 7 D, 7E), but prevent lock shaft 35 from back being slided from remote end, valve module is thus locked to supporting module.Can also Using other geometrical constructions, such as, but not limited to：Prismatic, circle, arrow-shaped, rivet shape, ball/bulb-shaped and permission one direction Mobile respective shapes.

Assembling silk thread 80 is shown in Fig. 8 A and 8B, and through the formation ring of eyelet 46 of locking fork 45, and lock shaft 35 is aobvious Between the Kite locking fork jaw 47 and the locking fork cross part 49 of proximal end that are shown as being locked at the remote end of locking fork 45. Alternatively, assembling silk thread can pass through the eyelet of a locking fork around a part for supporting module and pass through The eyelet of neighbouring locking fork or two locking forks, is passed back through different thread guides (such as with being pitched corresponding to neighbouring locking The associated different thread guides of lock shaft) and form ring.Such arrangement is reduced valve module booting to branch The quantity of assembling silk thread required for hold mode block.In another alternative, assembling silk thread can pass through the one of supporting module Ring partly is formed, as described in the one side in US 2011/0172784A1, herein by reference It is introduced into herein.

In the case where valve frame includes dissection type pillar, dissection type pillar can include a pair of locking axle, that is, be located at The first lock shaft 135 in the first half portion (being hidden) of dissection type pillar and on the second half portion 28b of dissection type pillar The second lock shaft 136, as shown in Figure 9 A.In this way, because the first lock shaft 135 and the second lock shaft 136 are in lock Neatly moved on fixed fork jaw 47, therefore the first lock shaft 135 and the second lock shaft 136 are closed at valve module to be formed Columnar work structuring.As shown in Figure 8 B, the locking fork 45 with the locking fork jaw 47 shown in figures 9 b and 9 includes conduct The locking fork cross part 49 of backstop so that valve module will not be moved proximally in supporting module to heart.But In Fig. 9 B, it is thread guide 30 rather than lock to be placed in against locking fork cross part 49 and by lock shaft on locking fork 45 Dead axle.

In another embodiment of locking fork-lock shaft locking component, as shown in Figure 10 A-B, locking fork is mixing Formula locking pitches 50, and ring lock dead axle 37 can be neatly moved so that valve module to be locked on hybrid locking fork 50 Supporting module.The details of one embodiment of hybrid locking fork 50 is shown in Figure 11 A-C, and primary structural element is to separate Section and groove.Hybrid locking fork 50 includes section 51a, the 51b and groove 53 separated by slit 54, described elongated The permission of hole 54 section 51a, 51b are slightly toward when ring lock dead axle 57 is slided in the above to be bent each other, and ring lock Dead axle 37 can enter the groove 53 and be held on wherein, and ring lock dead axle 37 thus is locked in into hybrid locking fork 50 On.In embodiment shown in Figure 11 A-C, there are two sections, but the hybrid locking with more than two section is pitched It is within the scope of the invention.Figure 11 A show eyelet 52, section 51a, 51b and groove 53.Figure 11 b show annular lock Axle 7 is neatly moved on hybrid locking fork 50.Figure 11 C show that ring lock dead axle is placed in the groove of hybrid locking fork 50 In 53 (being hidden by ring lock dead axle), valve module is thus locked to supporting module.

In the further embodiment of locking component, as shown in Figure 12 A-B and Figure 13 A-B is unilateral hybrid locking Fork 60, the unilateral locking fork 60 includes locking fork jaw 61 and bar portion area 68, the bar portion area 68 and multiple ring lock dead axles 66th, 67 and/or the cooperation of lock shaft 65a, 65b so that valve module is locked into supporting module.Locking fork jaw 61 is included by elongated hole Single-groove groove 63 and eyelet 62 on the outward flange of two separated sections of hole 64 and a section in the section.It is unilateral The locking fork jaw 61 of locking fork 60 can be with the diameter smaller than bar portion 68 and/or the first end court from positioning perforation 62 It is tapered to groove 63, but be flared out (flare) on side to be formed just in the top of groove 63 in Figure 12 B and 13B It can be seen that wedge-shaped part.Diameter or width of the locking fork jaw 61 at the wedge-shaped part is not above the straight of bar portion 68 Footpath or width.Assembling silk thread can be placed through the eyelet 62 at the top of the locking fork jaw 61.

Figure 12 A-B illustrate 60 (the single-groove groove springlocks) of unilateral locking fork being locked in ring lock dead axle 66 and 67, institute State ring lock dead axle 66 and 67 and be attached to pillar 25.Figure 12 A show positioned at locking fork 60 bar portion area 68 on bottom or First annular lock shaft 66 and the top in the groove 63 of locking fork jaw 61 or the second ring lock dead axle 67.Locking fork 60 Include locking fork retainer 69 at bar portion area 68, the limitation first annular lock shaft 66 in bottom of retainer 69 is in locking fork 60 It is upper to advance.Figure 12 B are a sectional views, disclose the structure of locking fork jaw 61, and the locking fork jaw 61 is included in each end End combines two sections of (join), and described two sections limit hole 64.The outward flange of a section in the section It is upper that there is groove 63.Figure 12 B also illustrate the internal structure of upper and lower part ring lock dead axle 66,67.Ring lock dead axle 66,67 With inner chamber, the diameter of the inner chamber is large enough for locking fork 60 and coordinated above.The intracavity diameter of first annular lock shaft 66 Width with bar portion area 68 is essentially identical.The intracavity diameter of second ring lock dead axle 67 be less than bar portion area 68 width, and with Width or diameter of the locking fork jaw 61 at the position of groove are essentially identical, so as to allow its single-groove for being locked to locking fork 60 In groove 63.

One side locking fork 60 is particularly suitable for use in being combined with the lock shaft on dissection type pillar 128a, 128b, such as Figure 13 A-B institutes Show.Locking fork 60 in Figure 13 A-B and the locking fork in Figure 12 A-B 60 are identicals, but lock shaft is different to house subdivision Formula pillar 128a, 128b.As shown in FIG. 13A, dissection type pillar 128a can have locking fork 65a and be attached to dissection type pillar 128a ring lock dead axle 67, and dissection type pillar 128b can have the lock shaft 65b being attached to thereon, and all is described Lock shaft 65a, 65b and ring lock dead axle 67 can be slided on locking fork 60 with by together with the side-latch of valve module simultaneously And valve module is locked to supporting module.Figure 13 B are sectional views, disclose the structure-such as Figure 12 B institutes of locking fork jaw 61 Show-define the groove 63 on two sections of hole 64 and the outer surface of a section in the section.Figure 13 B are also opened up The internal structure of ring lock dead axle 67 and lock shaft 65a, 65b is shown.The intracavity diameter of lock shaft 65a, 65b and locking fork 60 The width or diameter in bar portion area 68 are essentially identical.The intracavity diameter of ring lock dead axle 67 is less than the width or diameter in bar portion area 68, And it is essentially identical with width or diameter of the locking fork jaw 61 at the position of groove 63, so as to allow it to be locked to locking fork In 60 single-groove groove 63.One side preferably, ring lock dead axle 67 and lock shaft 65b can be positioned in subdivision On one half portion 128b of formula pillar, and lock shaft 65a can be positioned on another half portion 128a of dissection type pillar. In an alternative aspect, in Figure 13 A-B as shown in ring lock dead axle 67 being the locking with smaller inside diameter An axle 65a region, it is located on a half portion 128a of dissection type pillar, and lock shaft 65b can be positioned in and cut open On another half portion 128b of fraction pillar.Other combinations that can be by lock shaft and ring lock dead axle and dissection type pillar 128a, 128b are used together, but the diameter of all ring lock dead axle/lock shafts is large enough in the bar portion area of locking fork 60 Slided on 68, in addition to being coupled to that in single-groove groove 63.

Any embodiment party being used together in single-groove groove one side locking fork 60 with pillar 25 or dissection type pillar 128a, 128b In formula, Breadth Maximum/diameter that locking fork jaw 61 opens portion or wedge-shaped part is not greater than the width/diameter in bar portion area 68, and And slit 68 plays at least one section for allowing locking to pitch jaw 61 when applying stress and bent towards another section. Therefore, lock shaft or ring lock dead axle 65a, 65b with larger intracavity diameter, 66 can be easily on locking fork jaw 61 Slide, bent without the section for pitching jaw will be locked towards slit 63.On the contrary, ring lock dead axle 67 (or lock shaft Annular lock shaft portion) have narrower intracavity diameter so that at least locking fork jaw 61 have open portion or wedge-shaped part Section bending, and therefore ring lock dead axle 67 enters and is shelved in groove 63.More specifically, first annular lock shaft 66 (i.e. the bottom lock shaft with larger intracavity diameter) is neatly moved on locking fork 60 first, but presses against pushing meanss On 81.In view of the section on the intracavity diameter of first annular lock shaft 66, the either side of slit 64 is in first annular locking Axle 66 is not bent when sliding in the above.Second ring lock dead axle 67 (i.e. the top lock shaft with smaller intracavity diameter) is so Just promoted afterwards using pushing meanss 81 on locking fork jaw.The slit 64 of locking fork jaw allows being located for hole 64 On at least one sidepiece of wedge-shaped part section bending so that the second ring lock dead axle 67 can be in tapered portion wedge-shaped part most Big open promotes in portion.The intracavity diameter of second ring lock dead axle 67 is designed to the width tight fit with groove 63, and Second ring lock dead axle 67 is buckled in the single-groove groove 63 of unilateral hybrid locking fork 60.

One side locking fork 60 and the annular lock on the hybrid locking fork shown in such as Figure 10 A-B and Figure 11 A-C Axle 67 and lock shaft 65a, 65b, the benefit of 66 combinations are that it allows locking fork and lock shaft to have narrower outer dia, Which in turn reduces total profile of valve module.Another, which is advantageous in that, needs less dynamic locking fork of pushing to pass through locking Axle.

As locking component, lock shaft and ring lock dead axle are designed to the interaction of locking fork pacify valve module Put in supporting module and lock together two EM equipment modules, and/or with the first end of closed flaps film module and Two ends.The various combinations of locking fork, lock shaft and ring lock dead axle can be used.Other locking components can make as replacement It is applied in combination with or with locking fork as described herein and lock shaft, and pushing meanss are except making valve member in assembling silk thread It can also be similarly used for engaging locking component outside upper traveling.

In some embodiments, thread guide can have other function.Make valve using pushing meanss In the case that module advances in supporting module and engages locking component, the thread guide 31 on the second ring, which can be provided, to be pushed away The surface of dynamic device applying power.Following non-limiting advantage can be provided using thread guide for the purpose：Avoid damaging Hinder leaflet tissue and/or prevent pushing meanss from being slid from ring surface.Similar, it is positioned at the situation of valve module in lock shaft Under, the remote end of lock shaft may be used as pushing member push valve member against surface.In some embodiments, silk Line guiding piece is also used as after lock shaft is sufficiently engaged with locking fork pitching " seat " of cross part (referring to example against locking Such as Fig. 9 B).

Reference picture 7A-E, the system that Fig. 7 A-E show the present invention, illustrate the valve of deployment and the assembling present invention further back The method of film device.In this embodiment, the eyelet shape that assembling silk thread 80 is pitched through thread guide 31 and through locking Cyclic and secondary return so that assembling silk thread 80 is through silk thread guiding before EM equipment module is loaded into induction system The mariages line of part.Referring to Fig. 8 A-B, 9A-B and 10B.In this way, dispose, deploy and be anchored on valve in supporting module 40 After at film implantation position, valve module 10 can dispose, open and make it to control (ride assembling silks downwards from conveying equipment Line 80 is towards supporting module 40 and enters in supporting module 40.Referring to Fig. 7 A-E.In another embodiment, silk thread is assembled It can lock the eyelet of fork through an eyelet for locking fork through another around supporting module and pass through another silk Line guiding piece is returned.It is arranged so as to reduce the quantity of required assembling silk thread and remains in one end of assembling silk thread Ability of the upper drawing to remove.

Pushing member 81 can be slided on assembling silk thread 80 and can be used for pushing half portion mould along assembling silk thread 80 Block 10.Pushing member 80 may, for example, be hollow pipe, and assembling silk thread 80 is passed through from the hollow pipe, and it can be via conveying System 87 is manipulated.Pushing member 81 can for from catheter deployment valve module and/or be used to help assemble valve module 10 and it is locked to supporting module 40.In any purposes in these purposes, assembling silk thread 80 keeps nervous so that half Portion's module 10 can be slided as in orbit on assembling silk thread.Thread guide 31 not only can be for relative to support The positioning of module 40 valve module 10, but also can be used in combination to be connected/attachment valve module 10 and branch with pushing member 81 Hold mode block 40.

(not shown), each locks fork and its eyelet can be positioned in valve module in another embodiment, locks Fixed fork jaw is located at the proximal end of locking fork, and lock shaft can be positioned in supporting module.In this embodiment, conduit Proximal end 41 that can be Jing Guo supporting module is advanced (referring to Figure 10 A) through supporting module and is used to lead on assembling silk thread Drawing, thus valve module drawing is entered in supporting module and pulls locking pitch into lock shaft.In another embodiment party In formula, locking fork can be positioned in valve module and lock shaft is positioned in supporting module, and methods described can be wrapped Including makes the conduit outside proximal end 41 beyond supporting module 40 advance and using assembling silk thread 80 (and optional pushing member 65) pull valve module 10 towards supporting module 40 and enter the drawing of valve module 10 in supporting module 40.

After valve module and supporting module are assembled and locked together, because each assembling silk thread 80 is mariages Line, therefore an end of assembling silk thread 80 can be pulled and departed from will assemble silk thread from the assembling valve device of implantation.

It can be carried out as follows using the system deployment of the present invention and the method for assembling modularized equipment：Make conveying equipment row Enter so that position of its remote end close to selected position, such as valve implantation；Supporting module is disposed from conveying equipment； Deploy supporting module at selected position (in the case where supporting module is not to self-deploy)；Valve mould is disposed from conveying equipment Block；Valve module is set to be advanced along assembling silk thread towards supporting module using pushing member；And moved up in corresponding locking fork Move each pillar in multiple pillars valve module is locked into supporting module.The moving step is additionally may included in lock The first lock shaft and the second lock shaft (or if lock shaft and lock on EM equipment module in fixed fork in mobile dissection type pillar If the position of fixed fork is opposite, then moves into locking fork and enter lock shaft), to form the valve module of work structuring.Another In one embodiment, valve module can be disposed before supporting module, and be positioned in supporting module natural valve Valve module is set to advance in supporting module after in film ring.In the substitution method, the conduit for accommodating supporting module can be with Advance and dispose through the valve module disposed, either conduit is further advanced and then valve module can be pulled to support In module, still exit conduit and pushing meanss are used to make valve module slide into supporting module on assembling silk thread.

As shown in Figure 7 A, supporting module 40 is deployed and is deployed at the selected position of blood vessel 90 (in order to show Purpose, blood vessel is shown as transparent pipe), and exit conduit 85 to provide space for deployment valve module 10.Assemble silk thread 80 Keep tensing and be for example in tense situation.The valve module that Fig. 7 B shows are folded is disposed from conduit 85, and the first ring element 21 can To see, valve leaflet is attached.In fig. 7 c, valve module is disposed and opened, but is also not located in work structure Make.It can be seen that the first half portion 28a and the second half portion of the first ring element 21, the second ring element 22, pillar 25, dissection type pillar 28b and valve leaflet 15.Assembling silk thread 80 is shown as tensing between supporting module 40, and the silk thread through valve module is guided Part (not shown) is simultaneously entered in conduit 85.Fig. 7 D illustrate pushing member and just disposed from induction system 87, and assembling silk thread 80 is still So keep nervous.Fig. 7 D and 7E show how pushing member 81 can be for being forced into supporting module 40 by valve module 10 In.

In some embodiments, the valve module disposed and opened can be adopted leads via assembling silk thread with the following method Draw in supporting module, this method further comprises making conveying equipment such as conduit advance, and passes through disposed valve from distal end Film module and the supporting module disposed and deployed reach the remote location (that is, more than the proximal end of supporting module) of supporting module And drawing assembling silk thread.Lock shaft can be pulled with by further pulling assembling silk on the locking fork jaw of locking fork Line and engage lock shaft and locking pitch.Alternatively, pushing meanss can enter support for valve module is pulled Lock shaft is pulled in module and on locking fork jaw.In terms of this of methods described, pushing meanss extend beyond conduit Remote end, i.e., fully exceed supporting module proximal end.Make pushing meanss advance effectively in this way tensing Assembling silk thread on pull, thus valve module drawing is entered in supporting module, and the locking of locking component, example is realized Such as lock shaft is pulled on locking fork jaw.In these embodiments, locking fork can be positioned on valve frame, locking fork Jaw is located at the proximal end of valve module, and lock shaft and/or ring lock dead axle are positioned in supporting module.

Figure 14 A-D are provided to show the structure of valve module of the present invention and supporting module.Figure 14 A are according to this based on displaying The schematic diagram of the figure of the embodiment of the valve frame 20 for valve module of invention.The details of valve frame 20 is shown, It is not attached valve leaflet.In this embodiment, valve frame 20 there is the first ring element 21, it is the second ring element 22, multiple Pillar 25 and pivotal point 70, the multiple pillar 25 include dissection type pillar, and the dissection type pillar includes dissection type pillar half Portion 28a, 28b.In this embodiment, the first ring element 21 (in the vertical) is wider than the second ring element 22, but with phase Same radial thickness.It also show the silk thread guiding in multiple first thread guides 30 on the first ring element 21 Part and a thread guide in multiple second thread guides 31 on the second ring element 22, second silk thread draw Guiding element 31 have be used for pushing member promote against surface.It also show exemplary locking component.Specifically, first Ring lock dead axle 37a and the second ring lock dead axle 37b are positioned on each pillar 25, and the first locking shaft component 135 is located at first On dissection type pillar half portion 28a, and the second locking shaft component 136 is positioned on the second dissection type pillar half portion 28b.

Figure 14 B and 14C are the schematic diagrames of the figure based on the embodiment for showing the supporting module 40 according to the present invention.This A little specific embodiments include locking fork 45 and one or more cave nest 43, as discussed above.Used in purpose In some embodiments of implantation to replace aortic valve, big cave nest 43 is preferably located at the remote end of supporting module, Wherein they can lay adjacent to coronary artery and provide arrival entrance coronarius.In some other embodiment, greatly The position of cave nest 43 and their size, which can be adjusted to be adapted to after implantation valve device, may want to conduit arrival The positions and dimensions of blood vessel.The embodiment of the supporting module 40 shown in Figure 14 B has diameter than close end and distal portion Narrower pars intermedia, such as " hourglass " shape as discussed above.The embodiment of the supporting module 40 shown in Figure 14 C exists There is the diameter wider than at proximal end, such as in " pears " shape at its remote end.Figure 14 C further illustrate valve module 20, The valve module 20 have the first ring element 21 and the second ring element 22, its using it is hybrid locking fork 150 and lock shaft and Ring lock dead axle is locked to supporting module 40.Observation is easier in the case where valve leaflet is not attached into valve frame to connect Connect.Assembling silk thread 80a, 80b are also show, specifically, assembling silk thread 80 is shown passed through the eyelet of hybrid locking fork With the thread guide 31 on the second ring element 22.Figure 14 D are to include the mixing of eyelet 152 in supporting module based on illustrating The schematic diagram of the figure of the details of the embodiment of formula locking fork 150.It also show the big cave nest 43 of supporting module.In Figure 14 B-D Hybrid locking fork 150 embodiment be different from Figure 11 A-C in show hybrid locking fork 5, but play with annular The similar effect of locking fork.

It will be appreciated by one skilled in the art that without departing from the spirit or scope of the present invention, can To carry out many deformations, increase, remodeling and other application to the content being especially shown and described in text.Therefore, by following right The scope of the present invention that claim is limited is intended to include all foreseeable deformation, increase, remodeling or applied.

Claims (33)

1. a kind of valve module for percutaneous modularization valve device, the valve module includes：

Valve frame；With

Multiple valve leaflets, are attached to the valve frame；

Wherein described valve frame include the first ring element and be connected to and from first ring element extend it is multiple Pillar, wherein the connection between the multiple pillar and first ring element is pivotal point, wherein in the multiple pillar A pillar be longitudinal dissection type pillar, longitudinal dissection type pillar have the first pillar half portion and the second pillar half portion,

Wherein described valve frame has the unassembled delivery configuration folded and is designed to incite somebody to action after disposing from conveying equipment It is assembled into work structuring.

2. valve module according to claim 1, wherein, the valve leaflet is crispaturaed into the unassembled conveying structure of folding Make.

3. valve module according to claim 1, wherein, the pivotal point is accommodated in the multiple pillar.

4. valve module according to claim 1, wherein, the valve frame further comprises the second ring element, described Multiple pillars are connected to second ring element, the multiple pillar be arranged in first ring element and the second ring element it Between, wherein the connection between the multiple pillar and second ring element is pivotal point.

5. valve module according to claim 4, wherein, the valve leaflet be attached to first ring element and From second ring element suspension.

6. valve module according to claim 5, wherein, the valve leaflet is seamed to first ring element.

7. valve module according to claim 5, further comprises the valve leaflet being attached to the second ring structure The small leaf joint of part.

8. valve module according to claim 7, wherein, the small leaf joint by with the valve leaflet identical material shape Into.

9. valve module according to claim 1, wherein, the valve leaflet is attached to longitudinal dissection type pillar And it is not attached to other the multiple longitudinal dissection type pillars.

10. valve module according to claim 4, wherein, first and second annular construction member in the folding not Assemble substantially linear under delivery configuration.

11. valve module according to claim 1, wherein, the valve frame is biased to the work structuring.

12. valve module according to claim 11, wherein, the valve frame is formed by shape-memory material.

13. valve module according to claim 1, wherein, the valve leaflet includes the first material and by the second material Material is attached to the valve frame by sandwich attachment.

14. valve module according to claim 4, wherein, first ring element is along the work structuring valve mould The longitudinal axis of block is wider than the second ring element.

15. valve module according to claim 1, wherein, the pivotal point is S-shaped or horse's hoe shape.

16. valve module according to claim 1, wherein, unassembled conveying structure of the multiple pillar in the folding Make down in a spiral manner around guiding piece silk thread.

17. valve module according to claim 4, wherein, one of described first and second annular construction member or all bag Include guiding piece silk thread.

18. a kind of percutaneous valve device of modularization of the valve module including any one of claim 1 to 16, further Including：

Supporting module, the supporting module has the delivery configuration of compression and the work structuring of expansion；With

Multiple complementary locking components, the multiple complementary locking component is used for the branch of the valve module and the expansion Hold mode block is locked on each other.

19. the percutaneous valve device of modularization according to claim 18, wherein, it is each in the complementary locking component Individual locking component includes locking fork and lock shaft, and the locking fork has first end and second end, the lock shaft assembling On the locking fork.

20. the percutaneous valve device of modularization according to claim 19, wherein, at least one in the locking fork includes Locking jaw at the first end and the locking fork cross part at the second end.

21. the percutaneous valve device of modularization according to claim 19, wherein, at least one complementary lock shaft and locking Fork includes ring lock dead axle and hybrid locking fork.

22. a kind of percutaneous valve device of modularization, including：

Valve frame, including the first ring element and multiple pillars, wherein one of the multiple pillar is with the first pillar half portion With longitudinal dissection type pillar of the second pillar half portion；

Supporting module, the work structuring of delivery configuration and expansion with compression；And

Multiple complementary locking components, wherein each including being positioned in the supporting module in the complementary locking component Locking fork and the lock shaft that is positioned on the valve frame, the lock shaft is assemblied on the locking fork with by the valve Film framework and the supporting module are locked on each other.

23. the percutaneous valve device of modularization according to claim 22, wherein, at least one in the locking fork includes Locking jaw at the first end and the locking fork cross part at the second end.

24. the percutaneous valve device of modularization according to claim 22, wherein, at least one mutual lock shaft and locking are pitched Pitched including ring lock dead axle and hybrid locking.

25. the percutaneous valve device of modularization according to claim 22, wherein, at least one mutual lock shaft and locking are pitched The second ring lock dead axle and one side including the first annular lock shaft with the first inside diameter, with the second inside diameter are mixed Box-like locking fork.

26. the percutaneous valve device of modularization according to claim 22, wherein, the valve frame includes the first ring structure Part, the second ring element and multiple pillars, the multiple pillar are connected to and are arranged between first and second ring element.

27. the percutaneous valve device of modularization according to claim 26, wherein, the lock shaft is positioned at the valve frame On the pillar of frame.

28. the percutaneous valve device of modularization according to claim 26, wherein, a pillar in the multiple pillar is Longitudinal dissection type pillar with the first pillar half portion and the second pillar half portion, the first pillar half portion has the first locking Axle, the second pillar half portion has the second lock shaft, and longitudinal axis of first lock shaft along the valve frame is determined Near-end of the position in second lock shaft.

29. the percutaneous valve device of modularization according to claim 22, wherein, the locking fork is hybrid locking fork, The locking fork includes the slit for extending through it and the first groove extended along its first side, wherein the locking Axle is ring lock dead axle.

30. the percutaneous valve device of modularization according to claim 29, wherein, the hybrid locking fork includes being positioned at it Second groove in second side.

31. the percutaneous valve device of modularization according to claim 29, wherein, the hybrid locking fork includes preventing described The locking fork retainer that lock shaft is moved over.

32. the percutaneous valve device of modularization according to claim 22, wherein, the locking fork further comprises at it certainly Eyelet on end, the eyelet is configured to receive the assembling silk thread passed through.

33. the percutaneous valve device of modularization according to claim 22, wherein, the locking fork jaw, which has, to be selected from the group Shape：Prismatic, rhomboid, trapezoidal, Kite, circle, rectangle, ellipse, arrow-shaped, spherical, avette and bulb-shaped.